Abu El-Enin M A, El-Wasseef D R, El-Sherbiny D T, El-Ashry S M
Department of Medicinal Chemistry, Faculty of Pharmacy, University of Mansoura, Mansoura, Egypt.
Int J Biomed Sci. 2009 Sep;5(3):261-6.
A simple and sensitive spectrophotometric method was developed for the determination of labetalol HCl (LBT) and lercanidipine HCl (LER) in pure form and in dosage forms. The method was based upon oxidation of the LBT and LER with Fe(+3) and the estimation of the produced Fe(+2) with 1,10-phenanthroline. The absorbance of the tris(1,10-phenanthroline) Fe(+2) complex was measured at 510 nm. Reaction conditions were optimized to obtain colored complex of higher sensitivity and longer stability. The absorbance concentration plots were rectilinear over the concentration rang of 5-90 and 1-20 μg/mL with lower detection limits of 0.74 and 0.01 μg/mL and quantification limits of 2.26 and 0.02 μg/mL for LBT and LER, respectively. The developed method was successfully applied for the determination of LBT and LER in bulk drugs and dosage forms. The common excipients and additives did not interfere in their determinations. There was no significant difference between the results obtained by the proposed and the reference methods regarding Student t-test and the variance ratio F-test.
建立了一种简单灵敏的分光光度法，用于测定纯品及剂型中的盐酸拉贝洛尔（LBT）和盐酸乐卡地平（LER）。该方法基于LBT和LER被Fe(+3)氧化，并用1,10-菲啰啉测定生成的Fe(+2)。在510nm处测量三（1,10-菲啰啉）Fe(+2)络合物的吸光度。对反应条件进行了优化，以获得灵敏度更高、稳定性更长的有色络合物。LBT和LER在5-90和1-20μg/mL的浓度范围内吸光度-浓度曲线呈线性，检测限分别为0.74和0.01μg/mL，定量限分别为2.26和0.02μg/mL。所建立的方法成功应用于原料药和剂型中LBT和LER的测定。常见的辅料和添加剂在其测定中不产生干扰。根据学生t检验和方差比F检验，所提出的方法与参考方法所得结果之间无显著差异。
